Back to resultsEffect of Using Two Different Construction Techniques of Nasoalveolar Molding Devices in Unilateral Cleft Lip and Palate Patients
Primary Purpose
Unilateral Cleft Lip and Palate
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Nasoalveolar molding device
Sponsored by
About this trial
This is an interventional treatment trial for Unilateral Cleft Lip and Palate
Eligibility Criteria
Inclusion Criteria:Good general health without any systematic disease, disability or other syndromes Non syndromatic unilateral cleft lip and palate Both genders Age less than one month Parents willing to participate in the study and sign informed consent Exclusion Criteria: Patients exhibiting systemic disease, disability or other syndrome, parents denying participating in the study or not given their informed consent
Sites / Locations
- Faculty of Dentistry ,Minya university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
conventionally constructed nasoalveolar molding devices (control group)
Digitally constructed nasoalveolar molding devices (test group)
Arm Description
control group: patients receiving conventionally constructed nasoalveolar molding devices
test group: patients receiving digitally constructed nasoalveolar molding devices
Outcomes
Primary Outcome Measures
Alveolar cleft width
measurement of width between two alveolar segments
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05837780
Brief Title
Effect of Using Two Different Construction Techniques of Nasoalveolar Molding Devices in Unilateral Cleft Lip and Palate Patients
Official Title
Three Dimensional Evaluation of Maxillary Arch Changes After Using Two Different Construction Techniques of Nasoalveolar Molding Devices in Unilateral Cleft Lip and Palate Patients (Randomized Controlled Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study includes Three Dimensional Evaluation of Maxillary Arch Changes After Using Two Different Construction Techniques of Nasoalveolar Molding Devices in Unilateral Cleft Lip and Palate Patients (Randomized Controlled Trial) Null hypothesis: there is no difference between using conventionally constructed nasoalveolar molding device and using digitally constructed nasoalveolar molding device
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Cleft Lip and Palate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
conventionally constructed nasoalveolar molding devices (control group)
Arm Type
Experimental
Arm Description
control group: patients receiving conventionally constructed nasoalveolar molding devices
Arm Title
Digitally constructed nasoalveolar molding devices (test group)
Arm Type
Experimental
Arm Description
test group: patients receiving digitally constructed nasoalveolar molding devices
Intervention Type
Other
Intervention Name(s)
Nasoalveolar molding device
Intervention Description
comparison between using conventionally and digitally constructed nasoalveolar molding devices
Primary Outcome Measure Information:
Title
Alveolar cleft width
Description
measurement of width between two alveolar segments
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Days
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:Good general health without any systematic disease, disability or other syndromes Non syndromatic unilateral cleft lip and palate Both genders Age less than one month Parents willing to participate in the study and sign informed consent
Exclusion Criteria:
Patients exhibiting systemic disease, disability or other syndrome, parents denying participating in the study or not given their informed consent
Facility Information:
Facility Name
Faculty of Dentistry ,Minya university
City
Minya
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Effect of Using Two Different Construction Techniques of Nasoalveolar Molding Devices in Unilateral Cleft Lip and Palate Patients
We'll reach out to this number within 24 hrs